Flat Medical, a medical technology company specialized in clinical safety solutions, has received 510(k) clearance from the US Food and Drug Administration for its EpiFaith syringe to deliver safe epidural locating solution.
Flat Medical has designed the EpiFaith syringe based on the LOR technique, and introduced it as a physician-centered safeguard for epidural analgesia, indicated for painless labor, surgical anesthesia and chronic pain management.
The company said that its EpiFaith is a compact device compatible with current epidural injection procedures and is equipped with a clear visual intuitive signal.
Compared with traditional practice that relies on the manual sense, the intuitive signal indicates the location of epidural space and prevents accidental puncture to dura.
Accidental punctures may adversely affect in the form of serious headache, paralysis, prolonged admission time, and related healthcare costs.
Stanford University Anesthesiology Department Professor Dr. Edward T. Riley said: “Post-dural puncture headache is a complication which unfortunately occurs in 1-2% of epidural procedures, when the needle is inadvertently advanced through the dura.
“EpiFaith is a novel device which has the potential to reduce this debilitating complication by providing a clear and objective indication for when the epidural space is encountered. EpiFaith may help both novice and expert proceduralists and reduce the suffering of thousands of patients.”
Flat Medical said that prior to the FDA clearance, EpiFaith secured CE certification in October 2018, and through FDA clearance, the company would officially launch the EpiFaith syringe by May, 2019.
Flat Medical chairman and CEO Dr. Joseph Luo said: “It’s an exciting news that we have taken a step to the safer and intuitive puncture scenario. Now we have the opportunity to deliver safe epidural locating to millions of patients in the US. EpiFaith for epidural is the start of our clinical safeguard pipeline, we will continuously ease the clinical risks through innovation on risky procedures.”
Flat Medical was established in 2015 by co-founders hailing from different backgrounds including biomechanical engineering, medical and mechanical engineering.
In addition, it focuses on analysis of current medical scenarios and then improve the user experiences by developing innovative medical devices that complies with existing behaviors.